Dercher Enterprises, Inc., DBA Gordon
Form 483 issued January 19, 2017 · Upper Darby, Pennsylvania
- Inspection
- Jan 4 – Jan 19, 2017
- Investigators
- Craig D. Zagata· David A. Oluwo
- Observations
- 1
- Pages
- 2
- FEI number
- 2510734
In short: On January 19, 2017, FDA issued a Form 483 with 1 observation to Dercher Enterprises, Inc., DBA Gordon in Upper Darby, Pennsylvania (FEI 2510734) after an inspection that ran Jan 4 – Jan 19, 2017. The investigators were Craig D. Zagata and David A. Oluwo. Most observations concern materials; the most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures).
At a glance
1 of 1 observations on this 483 concern materials.
Most cited: 21 CFR 211.84(d)(2) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Establishment of the reliability of the component supplier’s report of analyses is deficient in that the…
This inspection in context
Craig D. Zagata
11 documents · 2016–2021
Cites 211.100 (written procedures; deviations) more than any other section. Most of their documents are for sites in Pennsylvania.
The firmDercher Enterprises, Inc., DBA Gordon history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.84(d)(2)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Dercher Enterprises, Inc., DBA Gordon?
FDA listed 1 observation on this Form 483, mostly about materials. The most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures). The opening words of each observation are shown on this page.
Who inspected Dercher Enterprises, Inc., DBA Gordon?
Craig D. Zagata and David A. Oluwo are named on this Form 483, for the inspection of Jan 4 – Jan 19, 2017. Each investigator has a profile showing what they cite most.
When was Dercher Enterprises, Inc., DBA Gordon inspected by FDA?
The inspection ran Jan 4 – Jan 19, 2017, and the Form 483 is dated January 19, 2017.
How do I get the full Form 483 for Dercher Enterprises, Inc., DBA Gordon?
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